Systems and methods for coupling conductors to conductive contacts of electrical stimulation systems

ABSTRACT

An electrical stimulation lead includes a plurality of conductive contacts disposed at a distal end and a proximal end of a lead body. The plurality of conductive contacts includes a plurality of electrodes and a plurality of terminals. At least one of the conductive contacts is a first conductive contact that includes at least one adhesive aperture defined between an inner surface and an outer surface of the at least one conductive contact. A plurality of conductors each electrically couple at least one of the electrodes to at least one of the terminals. Each first conductive contact has a conductor associated with, and electrically coupled to that first conductive contact. The adhesive is disposed in proximity to the at least one adhesive aperture of at least one first conductive contact to adhesively couple that first conductive contact to the at least one associated conductor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 12/419,763 filed on Apr. 7, 2009, which is incorporated hereinby reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to improved systems and methods forcoupling conductors to conductive contacts of implantable electricalstimulation leads (or lead extensions), as well as methods of making andusing the conductive contacts and electrical stimulation systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

In one embodiment, an electrical stimulation lead includes a lead body,a plurality of conductive contacts, and an adhesive. The lead body has aproximal end, a distal end, and a longitudinal length. The plurality ofconductive contacts are disposed at the distal end and the proximal endof the lead body. The plurality of conductive contacts includes aplurality of electrodes and a plurality of terminals. The plurality ofelectrodes are disposed on the distal end of the lead. The plurality ofterminals are disposed on the proximal end of the lead. At least one ofthe conductive contacts is a first conductive contact that includes atleast one adhesive aperture defined between an inner surface and anouter surface of the at least one conductive contact. The plurality ofconductors each electrically couple at least one of the electrodes to atleast one of the terminals. Each first conductive contact has at leastone of the conductors associated with, and electrically coupled to thatfirst conductive contact. The adhesive is disposed in proximity to theat least one adhesive aperture of at least one first conductive contactto adhesively couple that first conductive contact to the at least oneassociated conductor.

In another embodiment, an electrical stimulation system includes anelectrical stimulation lead, a control module, and a connector forreceiving the lead. The electrical stimulation lead includes a leadbody, a plurality of conductive contacts, and an adhesive. The lead bodyhas a proximal end, a distal end, and a longitudinal length. Theplurality of conductive contacts are disposed at the distal end and theproximal end of the lead body. The plurality of conductive contactsincludes a plurality of electrodes and a plurality of terminals. Theplurality of electrodes are disposed on the distal end of the lead. Theplurality of terminals are disposed on the proximal end of the lead. Atleast one of the conductive contacts is a first conductive contact thatincludes at least one adhesive aperture defined between an inner surfaceand an outer surface of the at least one conductive contact. Theplurality of conductors each electrically couple at least one of theelectrodes to at least one of the terminals. Each first conductivecontact has at least one of the conductors associated with, andelectrically coupled to that first conductive contact. The adhesive isdisposed in proximity to the at least one adhesive aperture of at leastone first conductive contact to adhesively couple that first conductivecontact to the at least one associated conductor. The control moduleconfigured and arranged to electrically couple to the proximal end ofthe lead. The control module including a housing and an electronicsubassembly disposed in the housing. The connector having a proximalend, a distal end, and a longitudinal length. The connector configuredand arranged to receive the lead. The connector including a connectorhousing and a plurality of connector contacts disposed in the connectorhousing. The connector housing defining a port at the distal end of theconnector. The port configured and arranged for receiving the proximalend of the lead. The connector contacts configured and arranged tocouple to at least one of the plurality of terminals disposed on theproximal end of the lead.

In yet another embodiment, a method for forming an electricalstimulation lead includes coupling a plurality of spaced-apartconductive contacts to either end of a lead body. The conductivecontacts are separated from one another by spacers. The plurality ofconductive contacts include electrodes disposed on a distal end of thelead body and a plurality of terminals disposed on a proximal end of thelead body. At least one of the conductive contacts is a first conductivecontact that includes at least one adhesive aperture defined between aninner surface and an outer surface of the at least one conductivecontact. The electrodes are electrically coupled to the terminals viaconductors. At least one of the conductors is associated, andelectrically coupled, to the at least one first conductive contact. Anadhesive is dispensed over the at least one adhesive aperture toadhesively couple the at least one first connective contact to the atleast one associated conductor.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system, according to the invention;

FIG. 2 is a schematic view of another embodiment of an electricalstimulation system, according to the invention;

FIG. 3A is a schematic view of one embodiment of a proximal portion of alead and a control module of an electrical stimulation system, accordingto the invention;

FIG. 3B is a schematic view of one embodiment of a proximal portion of alead and a lead extension of an electrical stimulation system, accordingto the invention;

FIG. 4A is a schematic transverse cross-sectional view of one embodimentof a conductor-carrying element of a lead (or lead extension), theconductor-carrying element defining lumens, according to the invention;

FIG. 4B is a schematic transverse cross-sectional view of one embodimentof conductors disposed in lumens of the conductor-carrying element ofFIG. 4A, according to the invention;

FIG. 5 is a schematic perspective, longitudinal cross-sectional, andtransverse cross-sectional view of one embodiment of a conductivecontact configured and arranged for coupling to a lead (or leadextension), according to the invention;

FIG. 6A is a schematic longitudinal cross-sectional view of oneembodiment of the conductive contact of FIG. 5 disposed over an outerportion of a lead (or lead extension), the conductive contactelectrically coupled to a conductor disposed within the lead (or leadextension), according to the invention;

FIG. 6B is a schematic longitudinal cross-sectional view of oneembodiment of the conductive contact of FIG. 5 disposed over an outerportion of the lead (or lead extension) of FIG. 6A and electricallycoupled to a conductor disposed within the lead (or lead extension), theconductor also coupled to the lead (or lead extension), the conductivecontact, or both, by an adhesive input through adhesive aperturesdefined in the conductive contact, according to the invention;

FIG. 7 is a schematic perspective, longitudinal cross-sectional, andtransverse cross-sectional view of another embodiment of a conductivecontact configured and arranged for coupling to a lead (or leadextension), according to the invention;

FIG. 8A is a schematic longitudinal cross-sectional view of oneembodiment of the conductive contact of FIG. 7 disposed over an outerportion of a lead (or lead extension), a conductor disposed within thelead (or lead extension) electrically coupled to an inner surface of theconductive contact, according to the invention;

FIG. 8B is a schematic longitudinal cross-sectional view of theembodiment of the conductive contact of FIG. 7 disposed over an outerportion of the lead (or lead extension) of FIG. 8A, a conductor disposedwithin the lead (or lead extension) electrically coupled to a recessdefined in an outer surface of the conductive contact, according to theinvention;

FIG. 8C is a schematic longitudinal cross-sectional view of oneembodiment of the conductive contact of FIG. 7 disposed over an outerportion of the lead (or lead extension) of FIG. 8A and electricallycoupled to a conductor disposed within the lead (or lead extension), theconductor also coupled to the lead (or lead extension), the conductivecontact, or both, by an adhesive input through an adhesive aperturedefined in the conductive contact, according to the invention;

FIG. 8D is a schematic longitudinal cross-sectional view of oneembodiment of the conductive contact of FIG. 7 disposed over an outerportion of the lead (or lead extension) of FIG. 8A, an outer surface ofthe lead (or lead extension) ground to remove portions of an adhesiveextending outward from the adhesive aperture, according to theinvention; and

FIG. 9 is a schematic overview of one embodiment of components of astimulation system, including an electronic subassembly disposed withina control module, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to improved systems and methods forcoupling conductors to conductive contacts of implantable electricalstimulation leads (or lead extensions), as well as methods of making andusing the conductive contacts and electrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are notlimited to, an electrode lead (“lead”) with one or more electrodesdisposed on a distal end of the lead and one or more terminals disposedon one or more proximal ends of the lead. Leads include, for example,percutaneous leads, paddle leads, and cuff leads. Examples of electricalstimulation systems with leads are found in, for example, U.S. Pat. Nos.6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S.patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240;11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all ofwhich are incorporated by reference.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102, a paddlebody 104, and at least one lead body 106 coupling the control module 102to the paddle body 104. The paddle body 104 and the one or more leadbodies 106 form a lead. The paddle body 104 typically includes an arrayof electrodes 134. The control module 102 typically includes anelectronic subassembly 110 and an optional power source 120 disposed ina sealed housing 114. The control module 102 typically includes aconnector 144 (FIGS. 2 and 3A, see also 322 and 350 of FIG. 3B) intowhich the proximal end of the one or more lead bodies 106 can be pluggedto make an electrical connection via conductive contacts on the controlmodule 102 and terminals (e.g., 310 in FIGS. 3A and 336 of FIG. 3B) oneach of the one or more lead bodies 106. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the electrical stimulation systemreferences cited herein. For example, instead of a paddle body 104, theelectrodes 134 can be disposed in an array at or near the distal end ofthe lead body 106 forming a percutaneous lead, as illustrated in FIG. 2.A percutaneous lead may be isodiametric along the length of the lead. Inaddition, one or more lead extensions 312 (see FIG. 3B) can be disposedbetween the one or more lead bodies 106 and the control module 102 toextend the distance between the one or more lead bodies 106 and thecontrol module 102 of the embodiments shown in FIGS. 1 and 2.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 106, thepaddle body 104, and the control module 102, are typically implantedinto the body of a patient. The electrical stimulation system can beused for a variety of applications including, but not limited to, brainstimulation, neural stimulation, spinal cord stimulation, musclestimulation, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. The number of electrodes 134 in the array ofelectrodes 134 may vary. For example, there can be two, four, six,eight, ten, twelve, fourteen, sixteen, or more electrodes 134. As willbe recognized, other numbers of electrodes 134 may also be used.

The electrodes of the paddle body 104 or one or more lead bodies 106 aretypically disposed in, or separated by, a non-conductive, biocompatiblematerial including, for example, silicone, polyurethane,polyetheretherketone (“PEEK”), epoxy, and the like or combinationsthereof. The paddle body 104 and one or more lead bodies 106 may beformed in the desired shape by any process including, for example,molding (including injection molding), casting, and the like. Electrodesand connecting wires can be disposed onto or within a paddle body eitherprior to or subsequent to a molding or casting process. Thenon-conductive material typically extends from the distal end of thelead to the proximal end of each of the one or more lead bodies 106. Thenon-conductive, biocompatible material of the paddle body 104 and theone or more lead bodies 106 may be the same or different. The paddlebody 104 and the one or more lead bodies 106 may be a unitary structureor can be formed as two separate structures that are permanently ordetachably coupled together.

Terminals (e.g., 310 in FIGS. 3A and 336 of FIG. 3B) are typicallydisposed at the proximal end of the one or more lead bodies 106 forconnection to corresponding conductive contacts (e.g., 314 in FIGS. 3Aand 340 of FIG. 3B) in connectors (e.g., 144 in FIGS. 1-3A and 322 and350 of FIG. 3B) disposed on, for example, the control module 102 (or toother devices, such as conductive contacts on a lead extension, anoperating room cable, or an adaptor). Conductive wires (“conductors”)(not shown) extend from the terminals (e.g., 310 in FIGS. 3A and 336 ofFIG. 3B) to the electrodes 134. Typically, one or more electrodes 134are electrically coupled to a terminal (e.g., 310 in FIGS. 3A and 336 ofFIG. 3B). In some embodiments, each terminal (e.g., 310 in FIGS. 3A and336 of FIG. 3B) is only connected to one electrode 134. The conductorsmay be embedded in the non-conductive material of the lead or can bedisposed in one or more lumens (see e.g., FIGS. 4A-4B) extending alongthe lead. In some embodiments, there is an individual lumen for eachconductor. In other embodiments, two or more conductors may extendthrough a lumen. There may also be one or more lumens (not shown) thatopen at, or near, the proximal end of the lead, for example, forinserting a stylet rod to facilitate placement of the lead within a bodyof a patient. Additionally, there may also be one or more lumens (notshown) that open at, or near, the distal end of the lead, for example,for infusion of drugs or medication into the site of implantation of thepaddle body 104. In at least one embodiment, the one or more lumens maybe flushed continually, or on a regular basis, with saline, epiduralfluid, or the like. In at least some embodiments, the one or more lumenscan be permanently or removably sealable at the distal end.

In at least some embodiments, leads are coupled to connectors disposedon control modules. In FIG. 3A, a lead 308 is shown configured andarranged for insertion to the control module 102. The connector 144includes a connector housing 302. The connector housing 302 defines atleast one port 304 into which a proximal end 306 of a lead 308 withterminals 310 can be inserted, as shown by directional arrow 312. Theconnector housing 302 also includes a plurality of conductive contacts314 for each port 304. When the lead 308 is inserted into the port 304,the conductive contacts 314 can be aligned with the terminals 310 on thelead 308 to electrically couple the control module 102 to the electrodes(134 of FIG. 1) disposed at a distal end of the lead 308. Examples ofconnectors in control modules are found in, for example, U.S. Pat. No.7,244,150 and U.S. patent application Ser. No. 11/532,844, which areincorporated by reference.

In FIG. 3B, a connector 322 is disposed on a lead extension 324. Theconnector 322 is shown disposed at a distal end 326 of the leadextension 324. The connector 322 includes a connector housing 328. Theconnector housing 328 defines at least one port 330 into which aproximal end 332 of a lead 334 with terminals 336 can be inserted, asshown by directional arrow 338. The connector housing 328 also includesa plurality of conductive contacts 340. When the lead 334 is insertedinto the port 330, the conductive contacts 340 disposed in the connectorhousing 328 can be aligned with the terminals 336 on the lead 334 toelectrically couple the lead extension 324 to the electrodes (134 ofFIG. 1) disposed at a distal end (not shown) of the lead 334.

In at least some embodiments, the proximal end of a lead extension issimilarly configured and arranged as a proximal end of a lead. The leadextension 324 may include a plurality of conductive wires (not shown)that electrically couple the conductive contacts 340 to a proximal end348 of the lead extension 324 that is opposite to the distal end 326. Inat least some embodiments, the conductive wires disposed in the leadextension 324 can be electrically coupled to a plurality of terminals(not shown) disposed on the proximal end 348 of the lead extension 324.In at least some embodiments, the proximal end 348 of the lead extension324 is configured and arranged for insertion into a connector disposedin another lead extension. In other embodiments, the proximal end 348 ofthe lead extension 324 is configured and arranged for insertion into aconnector disposed in a control module. As an example, in FIG. 3B theproximal end 348 of the lead extension 324 is inserted into a connector350 disposed in a control module 352.

Conductors may be disposed within a body of an elongated member (e.g., alead, lead extension, or the like) in any number of differentarrangements. FIG. 4A is a schematic transverse cross-sectional view ofone embodiment of a conductor-carrying element 402 that may extend alongat least a portion of a longitudinal length of a body of an elongatedmember. The conductor-carrying element 402 defines multiple lumens. Forexample, in FIG. 4A, and in other figures, the conductor-carryingelement 402 defines a central lumen 404 and conductor lumens 406-413. Itwill be understood that some embodiments may not include the centrallumen 404. In at least some embodiments, the conductor-carrying element402 may additionally include one or more layers of material disposedover or around one or more portions of the conductor-carrying element402.

In at least some embodiments, one or more conductors extend along atleast a portion of a longitudinal length of the conductor-carryingelement 402 within one of the conductor lumens 406-413. FIG. 4B is aschematic transverse cross-sectional view of one embodiment ofconductors 420-427 disposed in the conductor-carrying element 402. In atleast some embodiments, insulation 430 is disposed around a longitudinallength of one or more of the conductors 420-427.

In at least some embodiments, ends of the conductors 420-427 are coupledto conductive contacts (e.g., electrodes, terminals, or the like). Forexample, one set of ends of the conductors 420-427 disposed in a leadmay couple to electrodes (e.g., electrodes 134 of FIGS. 1 and 2) and theopposing set of ends of the conductors 420-427 may couple to terminals(e.g., terminals 310 of FIGS. 3A and 336 of FIG. 3B). It will beunderstood that conductors may, alternatively, extend along bodies withdifferent lumen arrangements, as well as bodies that do not definelumens at all. In some embodiments, one or more lumens may housemultiple conductors. In other embodiments, one or more lumens may nothouse any conductors.

Conductors can be formed using any conductive, biocompatible material.Examples of suitable materials include metals, alloys, conductivepolymers, conductive carbon, and the like, as well as combinationsthereof. For example, in at least some embodiments, conductors areformed from silver and nickel-cobalt-chromium-molybdenum alloy.Conductors are typically electrically coupled to conductive contacts(e.g., electrodes, terminals, or the like) by welding (e.g., laser,resistance, or the like), soldering, mechanical deformation, or thelike. In at least some embodiments, conductors may be multi-filar andarranged in many different configurations (e.g., 1×7, 1×19, and thelike). Conductors may be formed from many different gauges.

Conductors may be exposed to various forces associated with implantationand patient movement after implantation. Accordingly, it is preferredthat conductors, and the bonds between the conductors and the conductivecontacts, have adequate strength to be able to withstand these forces.One way to increase strength is to increase the outer diameters ofconductors. However, it is also preferred to form bodies of elongatedmembers with outer diameters that are as small as possible to facilitateimplantation into patients.

In addition to employing conductors with adequate strength, it is also aconcern to provide a coupling between conductors and conductive contactswith a pull strength (i.e., the ability to withstand pulling on theconductor without the conductor uncoupling from the conductive contact)that is strong enough to withstand the various forces mentioned above.Unfortunately, conventional coupling techniques may not provide adequatepull strength to reliably maintain a coupling between conductors andconductive contacts.

A conductive contact (e.g., an electrode, a terminal, or the like) maydefine one or more adhesive apertures along a longitudinal length of theconductive contact. When the conductive contact is disposed at one endof an elongated member (e.g., a lead, lead extension, or the like) and aconductor is electrically coupled to the conductive contact, a curableadhesive may be passed through one or more of the adhesive apertures andallowed to cure, thereby coupling the conductor to the elongated member,the conductive contact, or both. In at least some embodiments, theadhesive provides additional pull strength to the coupling between theconductor and the conductive contact.

FIG. 5 is a schematic perspective, longitudinal cross-sectional, andtransverse cross-sectional view of one embodiment of a conductivecontact 502. The conductive contact 502 includes adhesive apertures 504defined along a longitudinal length (represented by arrow 506). In atleast some embodiments, the conductive contact 502 has a cylindricalshape. In at least some embodiments, the conductive contact is C-shaped.In at least some embodiments, a diameter of the conductive contact 502is no greater than the longitudinal length 506 of the conductive contact502.

There may be any number of adhesive apertures 504. For example, theremay be one, two, three, four, five, six, seven, eight, nine, ten, ormore adhesive apertures 504. It will be understood that there may beother numbers of adhesive apertures 504, as well. The adhesive apertures504 may be of any size or shape. In preferred embodiments, at least oneof the adhesive apertures 504 is large enough that an adhesive can beinput through the adhesive aperture 504. In at least some embodiments,the adhesive apertures 504 are formed by drilling (e.g., laser cutting,conventional drilling, or the like) one or more holes through theconductive contact 502. In at least some embodiments, the adhesiveapertures 504 are burned through the conductive contact 502 usingelectro-discharge machining. In at least some embodiments, there are atleast two adhesive apertures where adhesive can be input into oneaperture and displaced air can escape through another aperture.

In at least some embodiments, the conductive contact 502 also defines atleast one contact aperture 508. The contact aperture 508 may be of anysize or shape. In at least some embodiments, the contact aperture 508 ispositioned in proximity to one of the edges (or ends) of the contactaperture 508 (see e.g., FIG. 7). In at least some embodiments, thecontact aperture 508 is a notch defined in one end of the conductivecontact 502. In preferred embodiments, the contact aperture 508 is largeenough that underlying conductors can be blind welded to the conductivecontact 502 via the contact aperture 508. In at least some embodiments,at least one of the adhesive apertures 504 is longitudinally alignedwith the contact aperture 508 along the longitudinal length 506 of theconductive contact 502. It may be an advantage to align the adhesiveapertures 504 with the contact aperture 508 so that, after welding theunderlying conductor to the conductive contact 502, the underlyingconductor is centered under the adhesive apertures 504.

In at least some embodiments, the contact aperture 508 is positioned inproximity to a lateral end of the conductive contact 502. In otherwords, when the conductive contact 502 is an electrode disposed on adistal end of a lead, in at least some embodiments the contact aperture508 is positioned in proximity to a distal end of the electrode.Similarly, when the conductive contact is a terminal disposed on aproximal end of a lead (or lead extension), in at least some embodimentsthe contact aperture 508 is positioned in proximity to a proximal end ofthe terminal.

FIG. 6A is a schematic longitudinal cross-sectional view of oneembodiment of a portion of a body 602 of an elongated member 600. Theconductive contact 502 is disposed along an outer surface of the body602. A conductor 604 is disposed in the body 602 and is electricallycoupled to the conductive contact 502. In at least some embodiments, theconductor 604 is electrically coupled to the conductive contact via oneor more welds 606 (e.g., formed by resistance welding, laser welding, orthe like). Other methods of attaching the conductor to the conductivecontact can also be used. In at least some embodiments, the welding 606is performed via the contact aperture 508, as shown by directional arrow608.

In at least some embodiments, insulation 610 is disposed around theconductor 604. In at least some embodiments, the insulation 610 isremoved at the portion of the conductor 604 electrically coupled to theconductive contact 502. In at least some embodiments, the conductor 604is disposed in a lumen 612 defined in the body 602, such as one of thelumens (406-413 of FIG. 4A) of the conductor-carrying element (402 inFIG. 4).

Typically, the conductor 604 is electrically coupled to the conductivecontact 502 such that the conductor 604 extends beneath at least one ofthe adhesive apertures 504. In at least some embodiments, the conductor604 is electrically coupled to the conductive contact 502 at (or inproximity to) a lateral end (or edge) of the conductive contact 502(i.e., a distal end of an electrode or a proximal end of a terminal).

In at least some embodiments, an adhesive may be input (e.g., injected,poured, pumped, flowed, or the like) through one or more of the adhesiveapertures 504, as shown by directional arrows 614. In preferredembodiments, the adhesive flows during application and subsequentlycures, sets, or cross-links (or any combination thereof), therebycoupling the conductor 604 to the conductive contact 502, the body 602,or both. In at least some embodiments, the adhesive mechanically couplesthe conductor 604 to the conductive contact 502, the body 602, or both.In at least some embodiments, the adhesive is electrically conductiveand electrically couples the conductor 604 to the conductive contact502, the body 602, or both. In at least some embodiments, the adhesiveis input through one or more of the adhesive apertures 504 such that airis allowed to evacuate the region of the body 602 into which theadhesive is input via one or more of the other adhesive apertures 504.

FIG. 6B is a schematic longitudinal cross-sectional view of oneembodiment of an adhesive 620 input through the adhesive apertures 504and cured within the body 602. Many different types of biocompatibleadhesives may be used including, for example, natural adhesives,synthetic adhesives, drying adhesives, contact adhesives, light curingadhesives, pressure curing adhesives, reactive adhesives, or the like orcombinations thereof. In at least some embodiments, the adhesive is anepoxy (e.g., a two-part thermoset epoxy adhesive, or the like). In atleast some embodiments, a pull strength of the coupling of the conductor604 to the body 602, the conductive contact 502, or both, by theadhesive 620 is no less than a tensile strength of the conductor 604.

In at least some embodiments, a plurality of spaced-apart conductivecontacts are disposed at one end of the body 602. Each of the conductivecontacts are electrically coupled to a different conductor disposed inthe body 602. In at least some embodiments, adjacent conductive contactsare separated from one another by non-conductive spacers. In at leastsome embodiments, the spacers are formed from polyurethane.

In at least some embodiments, the conductive contacts and interveningspacers are reflowed together. In at least some embodiments, when thebody 602 defines lumens, the reflowing process seals the lumens at theends of the conductive contacts. Accordingly, in at least someembodiments, the adhesive 620 input through the adhesive apertures 504is contained in the lumen 612 housing the conductor 604 such that theadhesive 620 is prevented from flowing beyond either end of theconductive contact 502 by seals 622 formed during the reflow process.

FIG. 7 is a schematic perspective, longitudinal cross-sectional, andtransverse cross-sectional view of another embodiment of a conductivecontact 702. The conductive contact 702 includes an adhesive aperture704 defined along a longitudinal length, represented by arrow 706, ofthe conductive contact 702. The adhesive aperture 704 includes a recess708 with a first opening 710 defined in the recess 708. It will beunderstood that a plurality of adhesive apertures 704 may be defined inthe conductive contact 702. In at least some embodiments, the firstopening 710 is configured and arranged to receive a conductor. In atleast some embodiments, the first opening 710 is defined at one end ofthe recess 708. In at least some embodiments, the adhesive aperture 704defines a second opening 712 defined in the recess 708. In at least someembodiments, the second opening 712 is defined at an opposite end of therecess 708 from the first opening 710. It will be understood that, in atleast some embodiments, the conductive contact 702 includes a pluralityof adhesive apertures 704.

FIG. 8A is a schematic longitudinal cross-sectional view of oneembodiment of a portion of a body 802 of an elongated member 800. Theconductive contact 702 is disposed along an outer surface of the body802. A conductor 804 is disposed in the body 802 and is electricallycoupled to the inner surface 716 of the conductive contact 702. Theconductor 804 extends through openings 710 and 712 defined in theadhesive aperture 704. In at least some embodiments, the conductor 804extends through the openings 710 and 712 defined in the adhesiveaperture 704 such that a portion of the conductor 804 extends across therecess 708 of the adhesive aperture 704, thereby exposing the portion ofthe conductor 804 to the outer surface 714 of the conductive contact702. In at least some embodiments, an adhesive may be disposed in therecess 708 of the adhesive aperture 704, as shown by directional arrow806, and allowed to cure, thereby adhesively coupling (e.g.,mechanically coupling, electrically coupling, or both) the conductor 804to the conductive contact 702.

When the conductive contact 702 is disposed on the elongated member 800,the conductor 804 disposed within the elongated member 800 is extendedout through the first opening 710 of the adhesive aperture 704. As shownin FIG. 8B, in some embodiments the conductor 804 is electricallycoupled to the recess 708 defined in the outer surface 714 of theconductive contact 702. As shown in FIG. 8A, in other embodiments theconductor extends back through the adhesive aperture 704 andelectrically couples to an inner surface 716 of the conductive contact702. In at least some embodiments, the conductor is extended backthrough the adhesive aperture 704 through the second opening 712 definedin the adhesive aperture 704.

Once the conductor 804 is electrically coupled to the conductive contact702 (on either the inner surface 716 or the outer surface 714 of theconductive contact 702), adhesive may be disposed in the recess 708 ofthe adhesive aperture 704, thereby adhesively coupling the conductor 804to the conductive contact 702. In at least some embodiments, theconductor 804 is both mechanically and electrically coupled to therecess 708. It will be understood that the conductive contact 702 candefine a plurality of adhesive apertures 704. When the conductivecontact 702 defines a plurality of adhesive apertures 704, adhesive canbe applied in proximity to each of the adhesive apertures 704 toadhesively couple the conductor 804 to each of the recesses 708 suchthat the conductor 804 is mechanically coupled to at least one of therecesses 708 and electrically coupled to at least one of the recesses,in any combination. For example, in at least some embodiments, theadhesive mechanically couples the conductor 804 to one of the recesses708 and electrically couples the conductor 804 to the other of therecesses 708.

FIG. 8C is a schematic longitudinal cross-sectional view of oneembodiment of adhesive 810 disposed in the adhesive aperture (704 inFIG. 8A). In at least some embodiments, some of the adhesive 810 mayflow through the one or more of the openings (710 and 712 of FIG. 8A) ofthe adhesive aperture (704 in FIG. 8A) and into the body 802, asdiscussed above, with reference to FIG. 6B. In at least someembodiments, at least a portion of the adhesive 810 flows into a lumen812 of the body 802. In at least some embodiments, the adhesive 810 thatflows into the body 802 may be contained by one or more seals formedduring a reflow process, as discussed above, with reference to FIG. 6B.

It may be an advantage for the body 602 or 802 to be isodiametric. In atleast some embodiments, a portion 814 of the adhesive 610 or 810 mayextend outward from the adhesive apertures 504 or 704, respectively,following the input of the adhesive 610 or 810 into the access apertures504 or 704, respectively. In at least some embodiments, the portion 814of the adhesive 610 and 810 extending from the adhesive apertures 504 or704 may be removed. In at least some embodiments, the adhesive 610 and810 is compatible with center-less grinding. Thus, in at least someembodiments when a portion 814 of the adhesive 601 or 810 extends fromthe adhesive apertures 504 or 704, respectively, the extending portionsmay be ground down. FIG. 8D is a schematic longitudinal cross-sectionalview of one embodiment of the conductive contact 702 disposed along anouter surface of the body 802. The portion (814 in FIG. 8C) of theadhesive 810 extending from the adhesive aperture 804 has been grounddown such that the body 802 is isodiametric.

FIG. 9 is a schematic overview of one embodiment of components of anelectrical stimulation system 900 including an electronic subassembly910 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, power source 912, antenna 918,receiver 902, and processor 904) of the electrical stimulation systemcan be positioned on one or more circuit boards or similar carrierswithin a sealed housing of an implantable pulse generator, if desired.Any power source 912 can be used including, for example, a battery suchas a primary battery or a rechargeable battery. Examples of other powersources include super capacitors, nuclear or atomic batteries,mechanical resonators, infrared collectors, thermally-powered energysources, flexural powered energy sources, bioenergy power sources, fuelcells, bioelectric cells, osmotic pressure pumps, and the like includingthe power sources described in U.S. Patent Application Publication No.2004/0059392, incorporated herein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 918 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 912 is a rechargeable battery, the battery may berecharged using the optional antenna 918, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 916 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. A processor904 is generally included to control the timing and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 904 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 904 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 904 mayselect which electrode(s) are cathodes and which electrode(s) areanodes. In some embodiments, the processor 904 may be used to identifywhich electrodes provide the most useful stimulation of the desiredtissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 908 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor904 is coupled to a receiver 902 which, in turn, is coupled to theoptional antenna 918. This allows the processor 904 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 918 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 906 which isprogrammed by a programming unit 908. The programming unit 908 can beexternal to, or part of, the telemetry unit 906. The telemetry unit 906can be a device that is worn on the skin of the user or can be carriedby the user and can have a form similar to a pager, cellular phone, orremote control, if desired. As another alternative, the telemetry unit906 may not be worn or carried by the user but may only be available ata home station or at a clinician's office. The programming unit 908 canbe any unit that can provide information to the telemetry unit 906 fortransmission to the electrical stimulation system 900. The programmingunit 908 can be part of the telemetry unit 906 or can provide signals orinformation to the telemetry unit 906 via a wireless or wiredconnection. One example of a suitable programming unit is a computeroperated by the user or clinician to send signals to the telemetry unit906.

The signals sent to the processor 904 via the antenna 918 and receiver902 can be used to modify or otherwise direct the operation of theelectrical stimulation system. For example, the signals may be used tomodify the pulses of the electrical stimulation system such as modifyingone or more of pulse duration, pulse frequency, pulse waveform, andpulse strength. The signals may also direct the electrical stimulationsystem 900 to cease operation, to start operation, to start charging thebattery, or to stop charging the battery. In other embodiments, thestimulation system does not include an antenna 918 or receiver 902 andthe processor 904 operates as programmed.

Optionally, the electrical stimulation system 900 may include atransmitter (not shown) coupled to the processor 904 and the antenna 918for transmitting signals back to the telemetry unit 906 or another unitcapable of receiving the signals. For example, the electricalstimulation system 900 may transmit signals indicating whether theelectrical stimulation system 900 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 904 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

1. An electrical stimulation lead comprising: a lead body with aproximal end, a distal end, and a longitudinal length; a plurality ofconductive contacts disposed at the distal end and the proximal end ofthe lead body, the plurality of conductive contacts comprising aplurality of electrodes disposed on the distal end of the lead, and aplurality of terminals disposed on the proximal end of the lead; whereinthe plurality of conductive contacts comprise a first conductive contacthaving an inner surface and an outer surface, the first conductivecontact comprising a recess formed along a portion of the outer surfaceof the first conductive contact, and a first adhesive aperture definedbetween the inner surface and the outer surface of the first conductivecontact, the first adhesive aperture defined in the recess; a pluralityof conductors, each of the plurality of conductors electrically couplingat least one of the electrodes to at least one of the terminals, whereinthe first conductive contact has at least one of the plurality ofconductors associated with, and electrically coupled to the firstconductive contact; and an adhesive disposed in proximity to the firstadhesive aperture to adhesively couple the first conductive contact tothe at least one associated conductor.
 2. The lead of claim 1, whereinthe at least one associated conductor extends through the first adhesiveaperture from inside the lead body to the outer surface of the firstconductive contact.
 3. The lead of claim 2, wherein the at least oneassociated conductor is electrically coupled to the outer surface of thefirst conductive contact.
 4. The lead of claim 2, wherein the firstconductive contact comprises a second adhesive aperture defined betweenthe inner surface and the outer surface of the first conductive contact,wherein the second adhesive aperture is defined in the recess, andwherein the at least one associated conductor extends through the secondadhesive aperture from the outer surface to the inner surface of thefirst conductive contact.
 5. The lead of claim 4, wherein the at leastone associated conductor is electrically coupled to the inner surface ofthe first conductive contact.
 6. The lead of claim 1, wherein theadhesive is disposed in proximity to the first adhesive aperture suchthat the adhesive is disposed in the recess.
 7. The lead of claim 1,wherein the lead body defines at least one lumen through which the atleast one associated conductor extends.
 8. The lead of claim 7, whereinthe adhesive is disposed in proximity to the adhesive aperture such thatthe adhesive is disposed in the lumen.
 9. The lead of claim 8, whereinthe adhesive is disposed in the lumen such that the adhesive iscontained beneath the first conductive contact by seals in the lumen ateither end of the first conductive contact.
 10. The lead of claim 1,wherein adhesively coupling the first conductive contact to the at leastone associated conductor comprises at least one of mechanically couplingthe first conductive contact to the at least one associated conductor orelectrically coupling the first conductive contact to the at least oneassociated conductor.
 11. The lead of claim 1, wherein the lead body isisodiametric.
 12. The lead of claim 1, wherein the first conductivecontact is one of cylindrical shaped or C-shaped.
 13. An electricalstimulating system comprising: a lead body with a proximal end, a distalend, and a longitudinal length; a plurality of conductive contactsdisposed at the distal end and the proximal end of the lead body, theplurality of conductive contacts comprising a plurality of electrodesdisposed on the distal end of the lead, and a plurality of terminalsdisposed on the proximal end of the lead; wherein the plurality ofconductive contacts comprise a first conductive contact having an innersurface and an outer surface, the first conductive contact comprising arecess formed along a portion of the outer surface of the firstconductive contact, and a first adhesive aperture defined between theinner surface and the outer surface of the first conductive contact, thefirst adhesive aperture defined in the recess; a plurality ofconductors, each of the plurality of conductors electrically coupling atleast one of the electrodes to at least one of the terminals, whereinthe first conductive contact has at least one of the plurality ofconductors associated with, and electrically coupled to the firstconductive contact; and an adhesive disposed in proximity to the firstadhesive aperture to adhesively couple the first conductive contact tothe at least one associated conductor; a control module configured andarranged to electrically couple to the proximal end of the lead body,the control module comprising a housing, and an electronic subassemblydisposed in the housing; and a connector for receiving the lead body,the connector having a proximal end, a distal end, and a longitudinallength, the connector comprising a connector housing defining a port atthe distal end of the connector, the port configured and arranged forreceiving the proximal end of the lead body, and a plurality ofconnector contacts disposed in the connector housing, the plurality ofconnector contacts configured and arranged to couple to at least one ofthe plurality of terminals disposed on the proximal end of the leadbody.
 14. The electrical stimulating system of claim 13, furthercomprising a lead extension having a proximal end and a distal end, theconnector disposed on the distal end of the lead extension.
 15. Theelectrical stimulating system of claim 14, wherein the lead extensioncomprises: a lead extension body with a proximal end, a distal end, anda longitudinal length; a plurality of terminals disposed at the proximalend of the lead extension body, wherein the plurality of terminalscomprises a first terminal having an inner surface and an outer surface,the first terminal comprising a first adhesive aperture defined betweenthe inner surface and the outer surface of the first terminal; aplurality of conductors, each of the plurality of conductorselectrically coupled to at least one of the plurality of terminals,wherein the first terminal has at least one of the plurality ofconductors associated, and electrically coupled, to the first terminal;and an adhesive disposed in proximity to the first adhesive aperture ofthe first terminal to adhesively couple the first terminal to the atleast one associated conductor.
 16. A method for forming an electricalstimulation lead, the method comprising: coupling a plurality ofspaced-apart conductive contacts to either end of a lead body, theconductive contacts separated from one another by spacers, the pluralityof conductive contacts comprising a plurality of electrodes disposed ona distal end of the lead body and a plurality of terminals disposed on aproximal end of the lead body, wherein the plurality of conductivecontacts comprises a first conductive contact having an inner surfaceand an outer surface, the first conductive contact comprising a firstadhesive aperture defined between the inner surface and the outersurface of the first conductive contact; electrically coupling theplurality of electrodes to the plurality of terminals via the pluralityof conductors, wherein at least one of the plurality of conductors isassociated, and electrically coupled, to the first conductive contact;and dispensing an adhesive over the first adhesive aperture toadhesively couple the first connective contact to the at least oneassociated conductor, wherein dispensing the adhesive over the firstadhesive aperture comprises dispensing the adhesive into a recess formedalong a portion of the outer surface of the first conductive contact.17. The method of claim 16, wherein electrically coupling the firstconductive contact to the at least one associated conductor comprisesextending the at least one associated conductor through a lumen definedin the lead body.
 18. The method of claim 17, wherein coupling theplurality of spaced-apart conductive contacts to either end of the leadbody further comprises reflowing the plurality of conductive contactsand adjacent spacers together such that the lumen seals on either end ofthe first conductive contact.
 19. The method of claim 16, whereindispensing an adhesive over the first adhesive aperture comprisesdispensing the adhesive through the first adhesive aperture into thelead body.
 20. The method of claim 16, further comprising grinding thefirst conductive contact to remove at least some adhesive from the outersurface of the first conductive contact.